An efficacy of honey and Clinacanthus nutans oil preparation on pressure ulcer treatment based on Thai Traditional Medicine (part 2)

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20160915004
• Date of registration: 15/09/2016
• Prospective Registration: No
• Primary sponsor: Mahidol University
• Public title: An efficacy of honey and Clinacanthus nutans oil preparation on pressure ulcer treatment based on Thai Traditional Medicine (part 2)
• Scientific title: An efficacy of honey and Clinacanthus nutans oil preparation on pressure ulcer treatment based on Thai Traditional Medicine (part 2)
• Date of first enrolment: 14/09/2016
• Target sample size: 64
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20160915004
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 2/Phase 3

Countries of recruitment

Thailand

Contacts

• Name: Sompop Prathanturarug
• Affiliation: Department of Pharmaceutical Botany Faculty of Pharmacy, Mahidol University

• Name: Sompop Prathanturarug
• Affiliation: Department of Pharmaceutical Botany Faculty of Pharmacy, Mahidol University

Key inclusion & exclusion criteria

Inclusion criteria: patient with pressure ulcer stage 2-4 or unstageable

Exclusion criteria: participant with health history about severe allergy on drugs that used in this study
participant with prognosis less than 6 weeks
participant who his/her physician make a decision to treat with a treatment that should not receive the treatments in this study

Age minimum: 18 Years
Age maximum: 100 Years
Gender: Both

Health Condition(s) or Problem(s) studied

pressure ulcer
bedsore
decubitus ulcer

pressure ulcer
pressure ulcer
bedsore
decubitus ulcer

Intervention(s)

Thai Traditional Medicine Practice,Modern Medicine Practice

Experimental Drug,Active Comparator Drug

Honey and/or Clinacanthus nuts oil preparation according to wound evaluation based on Thai traditional medicine ,topical agents following routine practices of study sites or clinical practice guideline

Primary Outcome(s)

PUSH 3.0 (Pressure Ulcer Scale for Healing) 6 weeks 1-17 scores

Secondary Outcome(s)

BWAT (Bates-Jensen Wound Assessment Tool) 6 weeks 5-65 Scores

Secondary ID(s)

PHD/0166/2554,CPR 5805020730

Source(s) of Monetary Support

Faculty of Pharmacy, Mahidol University

Secondary Sponsor(s)

The Royal Golden Jubilee Ph.D. Program,The Thailand Research Fund,Agricultural Research Development Agency (Public organisation)

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Committee on Human Rights Related to Research Involving Human Subjects

[phone] Ext.

Results

• Date Completed: 30/09/2017